Mitral cerclage annuloplasty appratus

ABSTRACT

A mitral cerclage annuloplasty apparatus comprises a tissue protective device and a knot delivery device. The tissue protective device comprises a first protective tube and a second protective tube. The knot delivery device comprises a tube wherein a loose knot is looped around its distal end through a hole and wherein tight knot is formed when the distal end of the tube is cut open. Alternatively, the knot delivery device comprises an inner tube and outer tube. The inner tube is insertable and rotatable inside the outer tube. When the tubes are in a closed position by rotating either the outer tube or the inner tube, a hole is created near its distal end. When the tubes are in open position by rotating either the outer tube or the inner tube, the hole joins the opening of the outer tube and lengthens.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a divisional application for U.S. Ser. No. 12/631,803, filed onDec. 4, 2009, which claims the benefit of U.S. Provisional ApplicationNo. 61/239,828 filed on Sep. 4, 2009 and claims foreign priority benefitof Korean Patent Application No. 10-2009-0080708 filed on Aug. 28, 2009which is incorporated herein in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to annuloplasty devices and techniques inwhich coronary sinus and tricuspid valve is protected from erosion usinga tissue protective device while maintaining appropriate tension byusing a knot delivery device.

BACKGROUND OF THE INVENTION

Heart is the center of human circulatory system that pumps blood throughour body. It is a muscle that pumps the blood only in one direction. Inorder for the heart to effectively keep this unidirectional flow ofblood, it must have properly functional valves that prevents back flowthrough its system, or regurgitation. Heart is divided into fourchambers, right and left atrium, and right and left ventricles. The fourchambers are connected to aorta, inferior and superior vena cava,pulmonary artery, and pulmonary veins.

Mitral valve (“MV”) separates left atrium from left ventricle whiletricuspid valve (TV) separates right atrium from right ventricle. Aorticvalve (“AV”) is located between left ventricle and aorta while pulmonaryvalve (“PV”) is located between right ventricle and pulmonary artery.

Generally, valves should open and close completely with every heart beator contraction. Incomplete opening and closing of the valves causesimproper flow of blood. Valvular diseases are divided into twocategories, regurgitation and stenosis. Regurgitation is a failure ofvalve to close completely and stenosis is a failure of valve to opencompletely.

Mitral valve regurgitation (“MVR”) is a common cardiac valve disorderthat is caused by incomplete closure of MV. MV is located between leftatrium and left ventricle. Over time, MVR burdens the heart and worsensits ability to pump blood properly. Such stress on the heart willultimately lead to heart failure.

Traditional treatment of worsening MVR requires an open heart surgerywith sternotomy or thoracotomy with cardiac arrest and cardiopulmonarybypass. Once the chest is open and access to heart is gained, MV iseither repaired or replaced using an artificial valve.

Although very effective, this open-heart procedure is a high risksurgery accompanied by substantial morbidity and prolongedconvalescence. Mortality due to surgery itself can be as high as 5%. Asa result, the procedure often is not offered to patients who areinsufficiently symptomatic to justify the surgical risk and morbidity,or to patients with substantial co-morbidity. It is reserved only forthose with severe symptomatic MVR.

This high morbidity rate of an open heart surgery has motivated furtherresearch to develop a safer and less risky alternative to repair MVR.Much of the research involves use of cardiac catheterization.

Recently, this inventor presented a thesis regarding “mitral valvecerclage coronary sinus annuloplasty (MVA)” showing outstanding resultof MVR treatment through applying circular pressure around the mitralannulus. This thesis has been filed through PCT as an internationalpatent application and published with its publication numberWO2008/060553, which is incorporated herein in its entirety.

Aforementioned thesis and published patent application disclosed themitral cerclage coronary annuloplasty (“MVA”) procedure. Brieflyexplained, a catheter is placed at coronary sinus after accessing theright atrium through the jugular vein, and then a cerclage suture ispassed through the proximal septal vein.

This cerclage suture can easily pass through right ventricular outflowtract (“RVOT”), and this inventor defines this technique as “simplemitral cerclage annuloplasty.” Then the cerclage suture can be easilypulled into the right atrium thus placing the cerclage suturecircumferentially around the mitral annulus.

Once positioned, tension is applied to the cerclage suture and tightenthe mitral valve. This brings together the two leaflets of MV, so thatthey are approximated and reduce the size of its incomplete closure.This theory can obtain very similar result that conventional surgeriescan obtain by directly tightening the mitral annulus, and show immediatereduction of MVR.

However, there are several technical problems to be solved. First, thereis needed to have a tension locking device to be able to apply propertension to the cerclage suture and maintain the tension.

According to the aforementioned research result, approximately 400-1200g tension is needed to have good treatment result. In addition,individualized tension must be applied constantly until the point wherethe mitral regurgitation is reduced, then, the suture needs to be fixedat that point, so that the same tension is maintained. Further, thistension must be sustained regardless of constant resistance from everybeat of each heart contraction.

Since this tension is maintained with a very fine cerclage suture (i.e.,0.014 nylon cerclage used in the researches), it can cause damages onthe neighboring cardiac tissues where the suture contacts and exertspressure. Especially, since the cerclage wraps around tricuspid valve(TV), it could affect the function of TV and damage the valve itself andits appendages. This invention is intended to provide viable solutionsto overcome these problems.

SUMMARY OF THE INVENTION

The objective of this invention is to overcome the shortcomings ofconventional MVA. In addition, this invention provides techniques anddevices designed for MVA to deliver proper, safe, and effective tensionon the cerclage suture.

The other objectives are to provide a protective device for tissues andprevent damage from direct tissue to cerclage suture contact. Inaddition, it provides a knot delivery device (“KDD”) which allows easierway of controlling, adjusting, and fixing the tension of the cerclagesuture, so that it can be customized for each individual patient. Itfurther provides tension locking function in which the fixed cerclagesuture is maintained without becoming loose.

This invention achieves the aforementioned objectives by using anapparatus described here. Generally, the apparatus comprises a tissueprotective device and a knot delivery device.

The tissue protective device comprises a first protective tube and asecond protective tube. The first tube and the second tube each have aproximal portion and a distal portion. The proximal portions of the twotubes are attached side-by-side longitudinally. The distal portions ofthe two tubes are separated thereafter.

In a first embodiment, KDD comprises a tube having a proximal end, ahole, and distal end, wherein a loose knot is looped around the distalend through the hole and wherein tight knot is formed when the distalend of the tube is cut open.

In a second embodiment, KDD comprises an inner tube and outer tube. Theinner tube and the outer tube each have a proximal end and a distal end.The inner tube is insertable and rotatable inside the outer tube. Thedistal ends of each tubes has an opening. The opening of the inner tubeis further divided into a small opening and a large opening.

When the tubes are in a closed position by rotating either the outertube or the inner tube, a hole is created near the distal end. Inaddition, when the tubes are in open position by rotating either theouter tube or the inner tube, the hole joins the opening of the outertube and lengthens.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a protection device in a particular embodiment, comprisinga coronary sinus tube, a tricuspid valve tube, a hinge portion, a stemportion, a ring-shape stopper, a coronary protection device, and acerclage suture.

FIG. 2 is a schematic view of cross-sectional top of a human heart,taken at the level of the atrioventricular valves, showing theprotective device in place.

FIG. 3 is a front view of the heart with portions of the myocardial wallremoved to show the protective device in place.

FIG. 4 is a set of drawings showing a knot delivery device (“KDD”) infirst embodiment using one tube configuration.

FIG. 4( a) shows KDD whose distal end has a hole in a closed positionwhere a loose knot is looped around the distal end through the hole.

FIG. 4( a) shows the distal end of the tube is cut off in open positionwhere tight knot is formed.

FIG. 5 is a set of drawings showing detailed steps of KDD operation in afirst embodiment.

FIG. 5( a) shows a step of making a loose knot around the distal end ofKDD through the hole using cerclage suture.

FIG. 5( b) shows a step of tension adjustment where the suture can bepulled or released until the mitral regurgitation stops.

FIG. 5( c) shows a step of cutting off (or opening) the hole, so thatthe loose knot is ready to form a tight knot.

FIG. 5( d) shows a step of tightening the knot while maintaing the rightamount of tension on the cerclage suture.

FIG. 5( e) shows a step of cutting off the cerclage suture.

FIG. 5( f) shows the final step of cerclage procedure.

FIG. 6 is a set of drawings showing detailed operation of KDD in asecond embodiment using an inner tube and an outer tube.

FIG. 6( a) shows KDD in closed position where a hole is created near thedistal end of KDD by rotating either the outer tube or the inner tube,so that a loose knot is formed around the distal end of KDD through thehole using cerclage suture.

FIG. 6( b) shows KDD in open position where an opening is created nearthe distal end of KDD by rotating either the outer tube or the innertube, so that a loose knot is ready to form a tight knot without cuttingin a step shown in FIG. 4( c).

DETAILED DESCRIPTION OF THE INVENTION

The detailed disclosure of mitral valve cerclage coronary sinusannuloplasty (“MVA”) comprising of coronary sinus and tricuspid valveprotective device (“CSTVPD”), and a knot delivery device (“KDD”) will bediscussed.

According to FIGS. 1-3, CSTVPD 20 comprises of a coronary sinus tube 22(“CS tube”) , a tricuspid valve tube 24 (“TV tube”), and stem portion26. CS tube 22 encircles coronary sinus (“CS”), and TV tube 24 encirclestricuspid valve (“TV”). Then, extension of CS tube 22 and TV tube 24meets and runs together to form stem portion 26.

Generally, conventional MVA techniques cause tissue damage (erosion) toCS, TV, and intraventricular septum (“IVS”) from direct cerclage sutureto tissue contact. These critical structures can be protected fromdamage by using CSTVPD 20 around the cerclage suture.

A part of CS is protected by coronary protective device 40 (“CPD”)introduced in the previous MVA thesis. Thus, only the remainder of CSwill need to be protected.

CSTVPD 20 has two separated tubes, CS tube 22 and TV tube 24 whichextend and form stem portion 26. The thickness of the tubes areapproximately 4 Fr diagnostic catheter made of flexible rubber orplastic like material. CSTVPD 20 is named because it protects both CSand TV.

In MVA procedure, first, a cerclage suture is fed through out CSTVPD 20starting at CS extension of stem portion 26, CS tube 22, CPD 40, TV tube24, and back out through TV extension of stem portion 26, or in reversedirection. Then, the suture-inserted CSTVPD 20 is pushed into the bodythrough a catheter and positioned within the heart.

Then, CS tube 22 is positioned to wrap around CS, and TV tube 24 ispositioned to wrap around TV leaflets. Since the cerclage suture 10 isinside the tubes and not in direct contact with the surrounding tissue,cardiac tissues around CS, TV and IVS are protected from damage from thecerclage suture 10.

CS tube 22 is a part of a coronary sinus protection device. CS tube 22starts at the orifice of CS to the beginning of CPD 40. Anatomically,this length varies from patient to patient. Thus, before the procedure,appropriate length can be determined using an estimation from CT orother imaging methods. CS tube 22 should be made of soft and flexiblecatheter like material, so that its affect on compression of CS isminimized.

TV tube 24 has tapering shape towards end. Starting from stopper 24 a,TV tube 24 passes through the muscle of IVS. Therefore, in order to easethe passing through the IVS muscle, TV tube 24 should taper from stopper24 a to the end.

In addition, TV tube 24 has a ring-shaped stopper 24 a (RVOT exitstopper 24 a) positioned about mid length of TV tube 24 to preventfurther advancement of TV tube 24 into the heart muscle.

Again, the length of TV tube 24 shall vary from patient to patient. Thelength shall be determined based on estimation from prior imagingstudies of individual patient.

Preferably, the length of TV tube 24 from hinge portion 27 to stopper 24a shall be derived by actual endocardial surface length from ‘RVOT exit’to ‘CS opening.’ It should be longer than actual endocardial surfacelength in order to be redundant. This distance from stopper 24 a to thetapered end of TV tube 24 shall be determined by preintervention imaginganalysis. Obviously, the location of stopper 24 a can vary as needed,and the length from hinge portion 27 to stopper 24 a can also varydepending on the need.

Hinge portion 27, where CS tube 22 and TV tube 24 meets, shall be placedat or near the orifice of CS. TV tube 24 will be fixed to the heart athinge portion 27 and at stopper 24 a. Then, hinge portion 27 to stopper24 a portion of TV tube 24 can be suspended freely in reverse “C” shapewithout being directly attached to the tissue. Such technique can reduceTV tissue damage resulting from direct contact of cerclage suture and italso reduces the restriction of cerclage on movement of TV leaflets.

TV tube 24 shall be rigid enough to resist being bent as tension isapplied onto cerclage suture. On the other hand, it shall be flexibleenough to bend in reverse “C” shape.

Stem portion 26 plays two roles. First, it stabilizes CS tube 22 and TVtube 24, so that their position is well maintained. Second, since hingeportion 27 rests on the orifice of CS, it prevents further advancementof CSTVPD 20 into the CS. Stem portion 26 (where CS tube 22 and TV tube24 are adjoined) should be made of of semi-rigid catheter like material.

FIG. 4 shows a knot delivery device 30 (“KDD”) in a first embodiment.KDD 30 is designed to transfer cerclage suture 10 looped and ready to beknotted to the upper portion of CSTVPD 20 while maintaining constanttension on the cerclage suture.

Once position and appropriate tension is verified, KDD 30 will releasethe loop and knot the suture in place thus ensuring the knot ispositioned in the right place with appropriate amount of tension.

One of the most crucial component of MVA procedure is having a devicethat can deliver and maintain necessary tension enough to applycompression on mitral annulus. That device should be (1) easy tooperate, (2) easy to manipulate cerclage suture tension depending onindividual patient variance, (3) easy to readjust and fix tension (4)then once cerclage suture is fixed, not become loose and maintainconstant tension well after the procedure.

FIG. 4 is a set of drawings showing KDD 30 in first embodiment using onetube configuration. FIG. 4( a) shows KDD 30 whose distal end has a holein a closed position where a loose knot is looped around the distal endthrough the hole. FIG. 4( a) shows the distal end of the tube is cut offin open position where tight knot is formed. FIG. 4( b) shows the distalend of the tube is cut off in open position where tight knot is formed.

KDD 30 is a catheter where a portion 32 of the distal end of KDD 30 canbe in closed position next to a hole 34 where a loose knot is loopedaround portion 32 through the hole. Portion 32 is cut off in openedposition where the loose knot becomes a tight knot.

KDD 30 should be made of sturdy material often used in diagnosticcatheters. It can be made of rubber or plastic like material strongenough to be pushed inside the body from outside.

As in FIG. 4( a) with portion 32 is in closed position, cerclage suture10 is made into a loop ready to be knotted at the distal end of KDD 30.Then, KDD 30 with the loosely knotted cerclage suture 10 is advancedinside the body and positioned appropriately. Then tension is appliedand adjusted. When position and tension is verified, portion 32 is cutoff as in FIG. 4( b), fixing the knot in place while maintaining thesame amount of tension on the cerclage suture.

FIG. 5 shows detailed steps of KDD 30 operation. FIG. 5 shows each stepsof KDD 30 during MVA procedure.

In summary, FIG. 5 is a set of drawings showing detailed steps of KDD 30operation in a first embodiment. FIG. 5( a) shows a step of making aloose knot around the distal end of KDD 30 through hole 34 usingcerclage suture 10. FIG. 5( b) shows a step of tension adjustment wheresuture 10 can be pulled or released until the mitral regurgitationstops.

FIG. 5( c) shows a step of cutting off (or opening) hole 34, so that theloose knot is ready to form a tight knot 12. FIG. 5( d) shows a step oftightening the knot while maintaing the right amount of tension on thecerclage suture. FIG. 5( e) shows a step of cutting off the cerclagesuture 10. Lastly, FIG. 5( f) shows the final step of cerclageprocedure.

According to FIG. 5, first, two strands of the cerclage suture 10 areinserted through hole 34 at the distal end of KDD 30. Second, twostrands are looped and made ready to form a knot 12. Third, the twostrands are passed through the body of KDD 30. Fourth, KDD 30 isadvanced into heart and positioned at the end of stem portion 26 ofCSTVPD 20. Hence, KDD 30 delivers cerclage suture knot to CSTVPD 20while keeping the knot 12 from tightening until it is ready to be fixed.

Then, appropriate amount of tension is applied to cerclage suture 10 andadjusted until mitral regurgitation ceases. In other words, tension onthe cerclage suture 10 is adjusted by pulling or releasing the strandsuntil the mitral regurgitation stops.

Once right amount of tension is achieved, portion 32 of KDD 30 is cutoff from KDD 30. Portion 32 of KDD 30 can be cut with a cutter or asexplained below in FIG. 4, various methods can be utilized.

When portion 32 is cut off from KDD 30, the loop tightens into a knot 12while maintaing the right amount of tension on the cerclage suture asshown in FIG. 5 (d), so that the end of cerclage suture is knotted atthe distal end of stem portion 26 of CVTVPD 20. Once knot 12 is placedand tightened at the end of stem portion 26, stem portion 26 can nowhold the two strands aligned and in place. This also enables knot 12from becoming loose even under significant amount of tension fromconstant beat to beat contraction of the heart.

At this stage, the cerclage suture 10 is cut at a certain distance fromthe knot 12 with a cutter as shown in FIG. 5( e). And then, theremainder of the cerclage suture 10 and KDD 30 is retracted from the thebody as shown in FIG. 5( f). Thus upon completion of CSTVPD 20procedure, CS tube 22 and TV tube 24 protects the surrounding tissuefrom cerclage suture 10 while maintaining constant tension on thecerclage suture 10.

FIG. 6 is a set of drawings showing detailed operation of KDD 30 in asecond embodiment using an inner tube 38 and an outer tube 36. Innertube 38 and outer tube 36 each have a proximal end and a distal end.Inner tube 38 is insertable and rotatable inside outer tube 36.

The distal end of inner tube 38 has opening 39. The opening 39 isfurther divided into a small opening 39 a and a larger opening 39 b. Thedistal end of outer tube 36 has opening 37.

When the tubes 38, 36 in a closed position by rotating either outer tube36 or inner tube 38, hole 34 is created near the distal end. Likewise,when the tubes 38, 36 in a opened position by rotating either outer tube36 or inner tube 38, hole 34 joins opening 37 of outer tube 36 andlengthens. Outer tube 36 and inner tube 38 are made of basic cathetertype of material.

FIG. 6( a) shows KDD 30 in closed position where hole 34 is created nearthe distal ends of KDD 30 by rotating either the outer tube 36 or theinner tube 38, so that a loose knot is formed around the distal ends ofKDD 30 through hole 34 using cerclage suture 10.

FIG. 6( b) shows KDD 30 in open position where an opening is creatednear the distal ends of KDD 30 by rotating either the outer tube 36 orthe inner tube 38, so that a loose knot is ready to form a tight knot 12without a cutting step shown in FIG. 4( c).

In a preferred embodiment, inner tube 38 has the small opening whoselength is L1 and diameter d2, and the large opening whose length is L2and diameter d3, wherein outer tube 36 has length less than or equal tothe sum of L1 and L2, and diameter d, and wherein d3 is wider or equalto the sum of d1 and d2.

While the invention has been described in terms of specific embodiments,it is apparent that other forms could be adopted by one skilled in theart. Accordingly, it should be understood that the invention is notlimited to the specific embodiments illustrated in the Figures. Itshould also be understood that the phraseology and terminology employedabove are for the purpose of disclosing the illustrated embodiments, anddo not necessarily serve as limitations to the scope of the invention.

1. A sets of devices for mitral valve annuloplasty, comprising: a tissueprotective device, the protective device having a first protective tubeand a second protective tube, the first tube and the second tube havinga proximal portion and a distal portion, the proximal portions of thetwo tubes being attached side-by-side longitudinally, the distalportions of the two tubes being separated thereafter, and a knotdelivery device comprising an inner tube and an outer tube having aproximal end and a distal end, wherein the inner tube is insertable androtatable inside the outer tube, wherein the distal ends of each tubeshas an opening, wherein the opening of the inner tube is further dividedinto a small opening and a large opening, wherein when the tubes are ina closed position by rotating either the outer tube or the inner tube, ahole is created near the distal end, and wherein when the tubes are inopen position by rotating either the outer tube or the inner tube, thehole joins the opening of the outer tube and lengthens.
 2. A sets ofdevice according to claim 1, wherein the tissue protective devicefurther comprises a ring-shaped stopper being positioned about midlength of the distal portion of the second tube to prevent furtheradvancement of the tube into heart muscle.
 3. A sets of device accordingto claim 1, wherein the distal portion of the second tube has a taperingshape towards the end to facilitate easy pass through muscle ofinterventricular septum.
 4. A sets of device according to claim 1,wherein the first tube is made of flexible rubber or plastic likematerial and has diameter of approximately 4 Fr diagnostic catheter. 5.A sets of device according to claim 1, wherein the distal portion of thefirst tube has an arched configuration so that the portion can bepositioned to encircle coronary sinus.
 6. A sets of device according toclaim 1, wherein the second tube is made of flexible rubber or plasticlike material and has approximately 4 Fr diagnostic catheter.
 7. A setsof device according to claim 1, wherein the distal portion of the secondtube is flexible enough to form an arch that encircles tricuspid valve.8. A sets of device according to claim 1, wherein the distal portion ofthe second tube is rigid enough to resist being bent inward as tensionis applied.
 9. A sets of device according to claim 1, wherein the innertube has the small opening whose length is L1 and diameter d2, and thelarge opening whose length is L2 and diameter d3, wherein outer tube haslength less than or equal to the sum of L1 and L2, and diameter d, andwherein d3 is wider or equal to the sum of d1 and d2.
 10. A knotdelivery device for mitral valve annuloplasty, comprising an inner tubeand an outer tube having a proximal end and a distal end, wherein theinner tube is insertable and rotatable inside the outer tube, whereinthe distal ends of each tubes has an opening, wherein the opening of theinner tube is further divided into a small opening and a large opening,wherein when the tubes are in a closed position by rotating either theouter tube or the inner tube, a hole is created near the distal end, andwherein when the tubes are in open position by rotating either the outertube or the inner tube, the hole joins the opening of the outer tube andlengthens.
 11. A sets of device according to claim 10, wherein the innertube has the small opening whose length is L1 and diameter d2, and thelarge opening whose length is L2 and diameter d3, wherein outer tube haslength less than or equal to the sum of L1 and L2, and diameter d, andwherein d3 is wider or equal to the sum of d1 and d2.